The Federal Circuit affirmed the district court’s denial of a motion for a preliminary injunction.  Here, the patents-in-suit involved new methods for using the drug Mitigare for treating acute gout.  The patentee Takeda contended that the accused infringer Hikma was liable for inducing infringement by selling Mitigare having a label that induced infringement by patients.  Relying on the Supreme Court’s Grokster decision and Federal Circuit cases that adopted its holding in the patent context, the court held that a drug label must demonstrate an intent to encourage, recommend, or promote infringement, not just describe the infringing mode.  This requirement is even more important in Hatch-Waxman cases, such as this one, because the statute was designed to enable the sale of drugs for non-patented uses even though this would result in some off-label infringing uses.  Although Hikma’s labels indicated non-infringing uses, Takeda argued that the label did instruct patients to consult his or her doctor under conditions that would likely cause the doctor to instruct the patient to use the drug in an infringing manner.  The court, however, held that such vague label language cannot be combined with speculation about how physicians may act to find inducement and therefore Takeda was unable to demonstrate a likelihood of success on its infringement case to support a preliminary injunction. 

In her dissent, Judge Newman argued that the court should not have created a bright-line rule of law that a provider of a known drug product, with knowledge that it is likely to be used in direct infringement, can never be liable for induced infringement.  She argued that these are fact-specific circumstances and thus require a trial on the facts of each case.

Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., Case No. 2015-1139, -1142 (May 6, 2015); Opinion by: Dyk, joined by Hughes, dissent by Newman; Appealed From: District Court for the District of Delaware, Robinson, J.  Read the full opinion here.

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